Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645639
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Implementation of P-INPAC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Towards Implementation of the Pediatric Integrated Nutrition Pathway for Acute Care Pathway P-INPAC - Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-INPAC
Brief Summary:
The framework for Pediatric Integrated Nutrition Pathway for Acute Care P-INPAC was developed by the Canadian Malnutrition Task Force CMTF however it has not been implemented in a research setting The framework by CMTF for Integrated Nutrition Pathway for Acute Care INPAC in adults was also implemented in the More-2-Eat project which led to development of best practices in nutritional culture of the hospitals Therefore we intend to undertake this feasibility project at 3-sites to train staff and evaluate the implementation of P-INPAC components as part of routine healthcare procedure
Detailed Description:
The P-INPAC pilot study will be a 3-phase multi-center research study in hospitalized children conducted at The Hospital for Sick Children Toronto and two other Canadian pediatric centres Centre hospitalier universitaire Sainte-Justine Montreal Quebec and McMaster Childrens Hospital Hamilton Ontario P-INPAC is an algorithm which helps to identify assess and treat children with malnutrition
In the first phase of the study we will perform an audit of health records of all hospitalized patients at one selected study ward one day of every other week for 8 weeks at each of the 3 study sites to track their routine nutrition care We anticipate auditing 80-100 patientssite in this cycle total 240-300 patients In addition 12- 20 patients site 60 in total who consent to detailed malnutrition screening and assessment would also be identified assessed and followed up one month after discharge In addition a questionnaire assessing the malnutrition knowledge attitude and self-perceived practices KAP amongst healthcare professionals will be conducted with staff including trainees at each sites study ward Further the workload of the study wards Registered Dietitian RD will be assessed for 3 days
In the second phase of the study the health care team from each sites study ward will be trained by the site implementation research team about the P-INPAC and how to administer nutritional screening and perform nutritional assessments which is the Subjective Global Nutrition Assessment SGNA
Finally in the third phase we will monitor and evaluate the implementation of the first 2 steps of the P-INPAC screening assessment over a period of 4 months assessing the acceptability adoption and coverage of improved nutrition care practices on the same pediatric study wards We anticipate auditing 160-200 patientssite in this cycle total 480-600 patients In addition detailed patient level data collection will take place in a selected group of consented patients 24-40 patients per site from the 3 sites 120 in total We would also follow-up with these patients a month after discharge
Healthcare providers will be invited to answer the KAP questionnaire post-implementation version We will compare responses from phase 1 with phase 3 pre- post-follow up And the workload of the ward RD will be assessed again over 3 days
In the first phase of the study we will perform an audit of health records of all hospitalized patients at one selected study ward one day of every other week for 8 weeks at each of the 3 study sites to track their routine nutrition care We anticipate auditing 80-100 patientssite in this cycle total 240-300 patients In addition 12- 20 patients site 60 in total who consent to detailed malnutrition screening and assessment would also be identified assessed and followed up one month after discharge In addition a questionnaire assessing the malnutrition knowledge attitude and self-perceived practices KAP amongst healthcare professionals will be conducted with staff including trainees at each sites study ward Further the workload of the study wards Registered Dietitian RD will be assessed for 3 days
In the second phase of the study the health care team from each sites study ward will be trained by the site implementation research team about the P-INPAC and how to administer nutritional screening and perform nutritional assessments which is the Subjective Global Nutrition Assessment SGNA
Finally in the third phase we will monitor and evaluate the implementation of the first 2 steps of the P-INPAC screening assessment over a period of 4 months assessing the acceptability adoption and coverage of improved nutrition care practices on the same pediatric study wards We anticipate auditing 160-200 patientssite in this cycle total 480-600 patients In addition detailed patient level data collection will take place in a selected group of consented patients 24-40 patients per site from the 3 sites 120 in total We would also follow-up with these patients a month after discharge
Healthcare providers will be invited to answer the KAP questionnaire post-implementation version We will compare responses from phase 1 with phase 3 pre- post-follow up And the workload of the ward RD will be assessed again over 3 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None